EPIX Getting Closer to FDA Approval
Written by: Israel Investor Newsletter | July 1, 2007
Douglas Goldstein,CFP
www.IsraelNewsletter.com
The U.S. FDA is known to be slower at approving new drugs than its foreign counterparts. In the case of EPIX Pharmaceuticals, in October 2005, the European Medicines Agency granted marketing approval of Vasovist for the 25 member states of the E.U., and Bayer Schering Pharma AG, Germany, EPIX’s partner for Vasovist, began marketing Vasovist in Europe in the second quarter of 2006. With the addition of Bulgaria and Romania to the E.U. in 2007, Vasovist is now approved in all 27 member states.
Last week, on the U.S. side, the company heard positive news from the Food and Drug Administration that said they might waive the requirement for one or two more clinical trials which they had previously required. This is beginning to lead to the company getting more analyst attention; Maxim Group just initiated coverage with a target price of $10.
EPIX has developed some close ties with some of the powerhouse pharmaceutical giants including GlaxoSmithKline (GSK) Amgen (AMGN), and Bayer Schering Pharma AG (BYERF.PK), Germany, the world’s market-leading MRI pharmaceutical company. Though the FDA approval could take half a year or longer, these critical alliances should help to insure quick access to the market for Vasovist, when and if they get the government’s OK. Vasovist is an injectable intravascular contrast agent designed to provide visual imaging of the vascular system through magnetic resonance angiography.
Disclosure: Author’s fund is does not own any of the companies mentioned herein as of 7/1/07.
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Douglas Goldstein is the Managing Director of America Israel Investment Associates, LLC. For more information, go to www.israelnewsletter.com or call 1-888-327-6179, or email doug@profile-financial.com.
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